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NCT07090226 · ClinicalTrials.gov registry record · NA
Diffuse Cutaneous Scleroderma (DSSc) SFDI Study
A NA study of Systemic Scleroderma and Diffuse Cutaneous Scleroderma, sponsored by Boston University.
- Recruiting
- Registry status
- NA
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT07090226 is a NA study of Systemic Scleroderma and Diffuse Cutaneous Scleroderma that is actively recruiting participants, run by Boston University. The registered enrollment target is 65 participants, above the 38-participant average among 4 other Systemic Scleroderma trials with a reported enrollment target (71% higher). The trial reports 1 study location across 1 state.
The verdict
NCT07090226, a NA study of Systemic Scleroderma and Diffuse Cutaneous Scleroderma, is actively recruiting participants, sponsored by Boston University.
- RECRUITING
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition) of the skin and internal organs. The extent of skin fibrosis is an important predictor of internal organ complications and increased mortality. Currently a very imprecise, subjective method that varies amongst different doctors for the same patient is used to quantify skin fibrosis in patients, by "pinching" their skin and assessing how thick it is; this is the method used to determine the modified Rodnan skin score (mRSS). A previous plot study was conducted by the investigators to determine if spatial frequency domain imaging (SFDI), a method of light scattering, could be used to measure the collagen content in the skin of SSc patients. This non-painful, noninvasive method takes very little time and the investigators hypothesized that it would be more accurate than the "pinching" method. For that pilot study, patients with various stages of the disease were selected, and SFDI was used to image 6 areas. A forearm skin biopsy was taken for subsequent histopathology analyses of collagen content. The clinical mRSS was assessed at the time of SFDI measurement. Optical property imaging data was analyzed and statistically correlated and analyzed with immunohistochemistry (a method of identifying proteins) of the skin. Preliminary results demonstrated a strong correlation between mRSS and SFDI. Some of the imaging parameters of the SFDI were modified based on the initial results. Initial results demonstrated that the device can detect increases in skin thickness observed in SSc skin.
Conditions Studied
Interventions
- OTHER Spatial-frequency domain imaging (SFDI)
Study Locations (1)
Massachusetts
- Shapiro Outpatient Rheumatology Clinic at Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2025-11-06 |
| Est. Completion | 2028-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07090226
The ClinicalTrials.gov registry entry for NCT07090226 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 38-participant average among 4 other Systemic Scleroderma trials with a reported enrollment target (71% higher). The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Systemic Scleroderma appearing as the primary indexed condition, and to 1 intervention - of which Spatial-frequency domain imaging (SFDI) is the first listed.
NCT07090226 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07090226 about?
NCT07090226 is a clinical study titled "Diffuse Cutaneous Scleroderma (DSSc) SFDI Study". Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition) of the skin and internal organs. The extent of skin fibrosis is an important predictor of internal organ complications and increased mortality. Currently a very imprecise, subjective method that varies amon...
What is the current status of trial NCT07090226?
This trial is currently recruiting. It is a NA study. The enrollment target is 65 participants. The study started on 2025-11-06. Estimated completion is 2028-12.
What conditions does trial NCT07090226 study?
This clinical trial studies the following conditions: Systemic Scleroderma, Diffuse Cutaneous Scleroderma.
What interventions are being tested in trial NCT07090226?
The interventions under investigation include: Spatial-frequency domain imaging (SFDI) (OTHER).
Who is sponsoring clinical trial NCT07090226?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07090226 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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